Controlled, prospective, multicentre, open, randomized study to investigate the contraceptive efficacy, bleeding patterns, metabolic effects, cycle-associated complaints, acceptance, and safety of an oral contraceptive containing 30 µg ethinylestradiol and 150 µg levonorgestrel, in two different regimens of intake (4 extended cycles of 91 days versus 13 conventional cycles of 28 days) in healthy wome

Phase 1

• Conditions: healthy volunteers (hormonal birth control using combined oral contraception); MedDRA version: 19.0Level: LLTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-004762-18-DE
• Lead Sponsor: Madaus GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-29
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria
1. Subject is informed, has been given ample time and opportunity to think about her participation and has given her written and personally dated informed consent obtained before undergoing any trial-specific procedure
2. Subject is a sexually active woman of child-bearing potential, at risk of pregnancy
3. Subject seeks contraception and agrees to use study COC as her primary birth control
method
4. Subject is aged between 18 and 35 years at screening (inclusive)
5. Subject is able to communicate, participate, and comply with the requirements of the
entire study
6. Subject is computer literate and able to complete the subject electronic diary
7. Subject has given her written specific consent to allow collection and use of contact
details for managing alert call.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1623
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Venous thrombosis present or in personal or family history (e.g. deep venous thrombosis, pulmonary embolism) in any body region
2. Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack) in any body region
3. Cerebrovascular accident present or in history
4. The presence of at least one severe or multiple risk factor(s) for arterial thrombosis, including:
• diabetes mellitus with vascular symptoms
• severe dyslipoproteinemia (i.e. screening total serum cholestero=l 240 mg/dl and/or LDL cholesterol =160 mg/dl, as per APT III guidelines , or use of anti-hyperlipidemic agents)
• valvular heart disease
• atrial fibrillation
5. Known hereditary or acquired predisposition for venous or arterial thrombosis, such as APC-resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant): such predisposing factors will not be specifically investigated, but patient personal and family history in this respect should be collected
6. History of other medical conditions associated with vascular AEs (e.g. haemolytic uremic syndrome, chronic inflammatory bowel disease such as Crohn’s disease or ulcerative colitis, sickle cell disease)
7. Hypertension defined as repeated measurements of systolic blood pressure >140 and diastolic blood pressure >90 mmHg
8. History of hereditary angioedema
9. History of migraine with focal neurological symptoms
10. Pancreatitis or a history thereof if associated with hypertriglyceridemia
11. Presence of hepatic disease (as per abnormal liver function at screening laboratory tests), or history thereof as long as liver function values have not returned to normal
12. History of being HIV or Hepatitis C positive
13. Presence or history of liver tumours (benign or malignant)
14. History of hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
15. Known or suspected sex-steroid influenced malignancies
16. Palpable breast tumours
17. Uterine fibroids
18. History of cervical cancer
19. HPV-positive at screening, PAP smear PAP III or higher
20. Known hypersensitivity to the active substances or to any of the excipients of Lisa coated tablets
21. BMI >30 kg/m²
22. Current smokers up to age 30 (inclusive) smoking more than 10 cigarettes/day
23. Subjects up to the age of 30 (inclusive) who consumed more than 10 cigarettes/day and either stopped smoking or reduced smoking to less than 10 cigarettes/day =24 months
24. Current smokers (or former smokers who stopped smoking = 24 months) aged more than 30 years
25. Desire to become pregnant during study period
26. Pregnancy or lactation period
27. Undiagnosed vaginal bleeding
28. Subjects who have had recent surgical or medical abortion, miscarriage or vaginal or cesarian delivery with less than three normal menstrual cycles prior to study enrolment
29. History of having used a contraceptive patch within 3 months prior to enrolment
30. History of having received injectable hormone contraceptives or other injectable hormones within the past 10 months prior to study enrolment
31. History of having a progestin-releasing intrauterine device in place over the 3 months prior to enrolment
32. Routine concomitant use of forms of contraception other than COCs with the exception of occasional condom use during t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified